Lead AdaptorRecalls & reported problems across all models

We found 3 models of Lead Adaptor by Oscor Inc. in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Jun 5, 2018 and Nov 21, 2025 — classified as 13 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Ambient Noise Problem” (7 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Lead Adaptor problems

Lead Adaptor models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Lead Adaptor BIS/BIS-40

  pacemaker lead Adaptor
  14 reports
• Lead Adaptor 666161-302

  pacemaker lead Adaptor
  4 reports
• Lead Adaptor BIS/BIS-17

  pacemaker lead Adaptor
  2 reports

Recent Lead Adaptor adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2025Ambient Noise Problem; Device Sensing Problem; Ambient Noise Problem; Device Sensing Problem

  PER CUSTOMER, WE RECEIVED THE FOLLOWING INFORMATION AND PORTIONS OF MYOPORE BP35, MODEL 360882 AND OSCOR IS-1 ADAPTOR (B)(6) (SERIAL NUMBER PORTION RECEIVED). EVENT OCCURRED IN US. NO PATIENT DEATH, HARM, OR INJURY WAS REPORTED. ON (B)(6) 2025 THE PATIENT'S DUAL CHAMBER PACEMAKER WAS EXPLANTED AND UPGRADED TO A CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER. THE CHRONIC MYOPORE RIGHT VENTRICULAR LEAD WOULD HAVE BEEN REUSED BUT WAS BEING EXPLANTED DUE TO NOISE AND SENSING ISSUES. DURING THE PROCEDURE, THE OSCOR IS-1 ADAPTOR WAS SEEN ON FLUOROSCOPY AND WAS ALSO REMOVED, IT IS UNKNOWN IF IT PLAYED A PART IN THE REPORTED ISSUES. THE CHRONIC MYOPORE RIGHT VENTRICULAR LEAD, AND OSCOR ADAPTOR, WERE SUCCESSFULLY EXPLANTED AT CLEVELAND CLINIC MAIN CAMPUS. DURING SAME PROCEDURE, A NEW MEDTRONIC EPICARDIAL RIGHT VENTRICULAR LEAD WAS SUCCESSFULLY IMPLANTED. WE HAVE NO PICTURES, IMAGES, OR VIDEOS TO SHARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622610 ↗
• MalfunctionJun 28, 2024High impedance; High Capture Threshold; High impedance; High Capture Threshold

  THE CUSTOMER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WITH A LEAD EXTENSION WAS EXHIBITING HIGH THRESHOLDS. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WITH A LEAD EXTENSION EXHIBITED HIGH THRESHOLDS, HIGH IMPEDANCE AND AN IMPEDANCE SPIKE. BOTH LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. NO INJURY NO HARM TO THE PATIENT. BOTH LEADS WITH LEAD EXTENSIONS REMAIN IN USE, NO INTERVENTION COMPLETED. NO INTERVENTION COMPLETED. IMPLANT DATE (B)(6) 2024, REMAINS IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19634579 ↗
• MalfunctionJun 28, 2023High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THE PATIENT WAS SCHEDULED FOR A PACEMAKER RELOCATION PROCEDURE ON (B)(6) 2023. TWO EXTENDERS WERE USED AND TUNNELED THE ABDOMEN. AT THE END OF PROCEDURE, MEASURES WERE WITHIN NORMAL LIMITS. RIGHT ATRIAL (RA) LEAD IMPEDANCE THROUGH DEVICE WAS 530-540 OHMS WITH THRESHOLD OF 0.5/0.4. ON THE MORNING OF (B)(6) 2023, THE RA IMPEDANCE WAS 1126 OHMS IN BIPOLAR AND 837 OHMS IN UNIPOLAR. DURING THE REVISION, THE PHYSICIAN RESET THE CONNECTION INVOLVING THE ATRIAL LEAD AND THE EXTENDER IN THE LEFT PECTORAL POCKET. THE IMPLANTABLE PULSE GENERATOR (IPG), RIGHT ATRIAL (RA) LEAD AND EXTENDER REMAIN IN USE. THERE WAS NO PROCEDURE DELAY AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17216229 ↗
• MalfunctionJan 5, 2023Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE LEAD EXTENDER EXHIBITED AN ADAPTOR MALFUNCTION AND WOULD NOT CONNECT TO THE LEAD. THIS RESULTED IN NO SIGNAL WHEN CONNECTED TO THE ANALYZER. THE LEAD EXTENDER WAS ATTEMPTED, NOT USED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16106543 ↗
• InjuryJul 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PATIENT IS AN 84 YEAR OLD, MALE, WITH THE INITIALS OF (B)(6). IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST REPLACEMENT PROCEDURE, THE PATIENT DEVELOPED A SYSTEMIC INFECTION. THE CARDIAC RE-SYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONALLY, IT WAS REPORTED THE PATIENT IS ALIVE WITH FURTHER INJURY, THE MANUFACTURER IS CURRENTLY INVESTIGATING INTO THIS MATTER. NO ADDITIONAL INFORMATION IS AVAILABLE. REFERENCE REPORT # 1035166-2022-00081.

  Patient problems: Unspecified Infection

  MAUDE report 14946471 ↗
• InjuryJul 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PATIENT IS AN 84 YEAR OLD, MALE, WITH THE INITIALS OF (B)(6). IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST REPLACEMENT PROCEDURE, THE PATIENT DEVELOPED A SYSTEMIC INFECTION. THE CARDIAC RE-SYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONALLY, IT WAS REPORTED THE PATIENT IS ALIVE WITH FURTHER INJURY, THE MANUFACTURER IS CURRENTLY INVESTIGATING INTO THIS MATTER. NO ADDITIONAL INFORMATION IS AVAILABLE. REFERENCE REPORT # 1035166-2022-00080.

  Patient problems: Unspecified Infection

  MAUDE report 14946409 ↗
• MalfunctionJun 13, 2022Low impedance; Low impedance

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE EXTENDER WAS CONNECTED TO EXISTING LEAD AND THEN CONNECTED TO THE IMPLANTABLE PULSE GENERATOR (IPG) AND LOW IMPEDANCE WAS NOTED 114 OHMS. THE PHYSICIAN PROCEEDED TO TEST THE ORIGINAL LEAD AFTER DISCONNECTING THE EXTENDER AND IT WAS WITHIN NORMAL LIMITS. THE EXTENDER WAS ATTEMPTED IMPLANT, NOT USED AND WAS REPLACED WITH ANOTHER EXTENDER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14675523 ↗
• InjuryJul 13, 2021High impedance; Loose or Intermittent Connection; High impedance; Loose or Intermittent Connection

  IT WAS REPORTED THAT WHEN THE DATA OF THE LEAD ITSELF WAS MEASURED AS IT WAS, THE PACING THRESHOLD WAS 2.8V X 0.5MS AND THE RESISTANCE WAS 900?, BUT WHEN IT WAS CONNECTED TO THE 6161 ADAPTER AND MEASURED, THE PACING THRESHOLD WAS OVER 5.0V AND THE RESISTANCE WAS OVER 3000?. ADDITIONALLY, THE CUSTOMER STATED THAT THEY WERE UNABLE TO DETERMINE THE CAUSE OF THE HIGH IMPEDANCES >3000 OHMS AND HIGH THRESHOLDS. WHEN THE LEAD WAS TESTED BY ITSELF, MEASUREMENTS WERE NORMAL, BUT WHEN CONNECTED TO THE ADAPTER, MEASUREMENTS WERE HIGH OUT OF RANGE. IT WAS SUSPECTED THERE WAS A POOR CONNECTION OF THE ADAPTER AND INCOMPLETE FRACTURE OF THE LEAD BUT COULD NOT BE CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12159451 ↗
• InjuryJun 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ADAPTOR UNIV2551 WAS UNABLE TO USE DURING THE PROCEDURE DUE TO UNKNOWN REASON. ADAPTOR UNIV2551 WAS AN ATTEMPTED IMPLANT. THERE WAS SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING DIFFERENT LEADS AND ACCESSORIES. THERE WAS SURGICAL INTERVENTION REPORTED BUT PATIENT OUTCOME IS UNHARMED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11975361 ↗
• InjuryFeb 24, 2021Ambient Noise Problem; Ambient Noise Problem

  IT WAS REPORTED THE LEAD ADAPTOR WAS SUSPECTED TO BE MALFUNCTIONING DUE TO NOISE. THE ADAPTOR WAS EXPLANTED. NO PATIENT COMPLICATION HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11371851 ↗
• InjuryFeb 23, 2021Ambient Noise Problem; Ambient Noise Problem

  IT WAS REPORTED THE LEAD ADAPTOR WAS SUSPECTED TO BE MALFUNCTIONING DUE TO NOISE. THE ADAPTOR WAS EXPLANTED. NO PATIENT COMPLICATION HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11367089 ↗
• InjuryFeb 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LEAD ADAPTORS WERE EXPLANTED BECAUSE OF RIGHT VENTRICULAR LEAD INFECTION. THERE WAS NO KNOWN ISSUE WITH ADAPTOR REPORTED. THE PATIENT'S IMPLANT SITE IS WELL HEALED WITH SWELLING THAT HAS IMPROVED. THERE ARE NO SIGNS OF INFECTION. THE GROIN ACCESS SITE HAS NO BRUISING WITH GOOD PULSE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 11314874 ↗
• InjuryFeb 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LEAD ADAPTORS WERE EXPLANTED BECAUSE OF RIGHT VENTRICULAR LEAD INFECTION. THERE WAS NO KNOWN ISSUE WITH ADAPTOR REPORTED. THE PATIENT'S IMPLANT SITE IS WELL HEALED WITH SWELLING THAT HAS IMPROVED. THERE ARE NO SIGNS OF INFECTION. THE GROIN ACCESS SITE HAS NO BRUISING WITH GOOD PULSE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 11314804 ↗
• InjuryNov 6, 2020High impedance; Over-Sensing; Under-Sensing; Ambient Noise Problem; Noise, Audible; High impedance; Over-Sensing; Under-Sensing; Ambient Noise Problem; Noise, Audible

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD AND EXTENDER LEAD EXHIBITED NOISE WITH MOVEMENT, HIGH IMPEDANCE AND UNDERSENSING. BOTH RA LEAD AND EXTENDER LEAD REMAINS IN USE. PATIENT IS A (B)(6) FEMALE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ON 2020-10-28 IT WAS FURTHER REPORTED THAT THE RA LEAD WAS CAPPED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10800412 ↗
• InjuryJun 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO AN INFECTION. THE ORGANISM WAS IDENTIFIED AS STAPHYLOCOCCUS EPIDERMIDIS. A NEW SYSTEM WILL BE IMPLANTED AT A LATER DATE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THERE WAS NO SPECIFIC ISSUE TO THE BIS/ BIS ADAPTOR REPORTED.

  Patient problems: No Consequences Or Impact To Patient; Unspecified Infection

  MAUDE report 10166992 ↗

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